Kornimate/medical-research-clean huggingface dataset:
restoration of the gut microbiome after cesarean section

Conditions: Microbial Colonization

Summary: this study aims to develop a therapy for restoring the gut microbiome in infants born via cs. the study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by fmt and fvt in infants born by cesarean section.

when a child is born vaginally, the passage through the birth canal provides the first and very important bacterial colonization. as the child ages, various environmental exposures, such as dietary changes and the presence of older siblings in the home, facilitate a natural maturation of the child's gut microbiome, providing a vast and continuous stimulation of the child's developing immune system. however, factors such as mode of delivery and intrapartum antibiotics can perturb this natural developmental process and cause long-term microbial derangements. the prevalence of cesarean section (cs) birth has increased globally in recent decades, and with it, antibiotic treatment to prevent perinatal infection. similar patterns have occurred for the prevalence of chronic childhood disease, particularly asthma, with an estimated 300 million asthmatic cases worldwide. the hypothesis is that early intervention with mother-to-infant fmt can restore a cs-perturbed microbiome to a normal microbial trajectory. another hypothesis is that seeding the virome fraction (fvt) will cause the neonate's microbiome to resemble the mother's since the transferred phages are enriched and preserved in the intestinal mucus layer, thereby providing the recipient with selective antimicrobial protection while allowing species resembling the mother's own to establish during subsequent bacterial transmission.

Eligibility criteria:
inclusion criteria: * gestational age \< week 38+0 days * proficient in spoken/written danish * single pregnancy (no twins or triplets) * pre-pregnancy bmi between 18.5 and 35 kg/m2 * no chronic intestinal, endocrine, cardiac, or kidney disorders * no known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism) * no regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results. * willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or a38 are allowed). exclusion criteria: maternal: * use of antibiotics within one month of stool donation * acute gastroenteritis within one month of stool donation * use of antibiotics within one month of birth * time since last travel abroad relative to data of fecal donation according to the requirements for blood donations ("regler for tappepauser" - blooddonor.dk) * positive test results for pathogens during donor material screening. * antibiotic treatment at birth (vaginal births only) * spontaneous onset of labor or emergency cesarean section before scheduled cesarean section. infant: * instances of major birth defects or intrauterine growth retardation (iugr) * infants requiring pediatric support at the time of transplant administration
safety study of gs-5806 to treat respiratory syncytial virus (rsv)

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of gs-5806 in hospitalized infants with rsv.


Eligibility criteria:
inclusion criteria: * \<24 months of age * diagnosis of respiratory syncytial virus (rsv) within 48 hours of screening exclusion criteria: * chronic or congenital heart disease * required ventilation or admission to any pediatric intensive care unit * inadequate organ function

Keywords: respiratory syncytial virus rsv
evaluation of survival of mature second premolar treated with regenerative techniques

Conditions: Carious Teeth

Summary: this study aims to compare the ability of different regenerative protocols in the treatment of mature necrotic

american dental association adopted the tissue engineering concept and pulp regeneration in 2009. regeneration was focused on the treatment of immature necrotic teeth so as to allow root completion, improving both the functionality and durability of the affected tooth. utilizing a blood clot in the affected tooth with immature roots was very beneficial, as it acts as a scaffold for the migration of stem cells and morphogens to allow regeneration . based on the success of pulp regeneration in treating immature teeth, ambitious dentists started to look forward on regenerating the pulp of mature teeth as a substitution to the conventional root canal treatment. on the other hand, lots of clinicians were very doubtful about treating mature teeth with the same protocol, as the small apical foramen might not provide a good portal for the entry of stem cells and growth factors, which in turn is very important for the success of pulp regeneration.doubts in treating mature apex encouraged researchers to look for an alternative to the stem cells other than the apical papilla, from this concept the idea for using an alternative source of stem cells and growth factors as platelet rich plasma (prp) emerged. the use of platelet rich plasma (prp) as a potentially ideal scaffold for regenerative endodontic therapy has been reported in the treatment of immature teeth. however, the use of bovine thrombin for the activation of prp has been an issue of controversy, as it requires non autologous anticoagulant known to hinder the process of pulp regeneration. this led to the development of the second generation, platelet concentrate known as choukroun's platelet rich fibrin (prf) which is totally autologous in nature. platelet rich fibrin (prf) was very promising, but it is debatable whether to use prp or prf.the objective of this study is to evaluate novel regenerative techniques, utilizing platelet rich plasma and platelet rich fibrin in treatment of second premolar teeth with necrotic pulp, mature apex, and periapical lesion. this is a trial to prolong the survival of the affected tooth, and to aid in complete healing of periapical lesion, and to regain pulp vitality and sensitivity.

Eligibility criteria:
inclusion criteria: * patients who are free from any physical or mental handicapping condition with no underlying systemic diseases. non-pregnant females single canalled second premolar * patients having non-vital, mature, second premolar teeth, radiographic evidence of periapical lesion. * positive patient/guardian compliance for participation in the study. exclusion criteria: * any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial. non-restorable coronal portion of teeth involved in the trial. vital teeth immature teeth traumatized teeth radiographic evidence of external or internal root resorption. any criterion, not mentioned in the inclusion criteria
thermal imaging in liver disease.

Conditions: Liver Diseases

Summary: this is a feasibility study, to assess if thermal imaging and/or near infrared imaging will be useful in identifying changes in the peripheral circulation in patients with different stages of liver disease. the aim of this study is to use new and advanced thermal imaging techniques to identify changes in the peripheral circulation and hand temperature in patients with liver disease. these changes could be used as a non-invasive marker of the severity and progression of liver disease. thermal imaging will also be used to assess the changes in the peripheral vasculature with the use of terlipressin, a drug used as treatment for specific complications of liver disease. patients with acute or chronic liver disease from any aetiology will be recruited, along with patients without liver disease as healthy controls. patients with disease or on drugs known to affect the peripheral vasculature will be excluded. all studies will be performed in a ward setting in the royal infirmary of edinburgh. the subjects will be required for up to three sessions, each lasting 30 minutes. the session will involve static thermal images being taken, and video images of the hands warming up after being cooled for 30 seconds in water at a temperature of 7 degrees celsius. if the patient is receiving terlipressin therapy, static images will be taken before, during and after terlipressin therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic liver disease (any stage) * diagnosis of acute liver disease (any aetiology) exclusion criteria: * on drugs known to affect peripheral circulation * conditions known to affect peripheral circulation e.g. raynauds
the use of the propeller health platform to improve inhaled corticosteroid (ics) use among adults with uncontrolled persistent asthma

Conditions: Asthma

Summary: this is a behavioral randomized controlled trial of adults with uncontrolled persistent asthma that tests if the propeller health sensor, mobile application, and dashboard can improve adherence to ics.


Eligibility criteria:
inclusion criteria: * under the care of a staff asthma physician (i.e. pulmonologist or allergist/immunologist) at northshore university healthsystem (ns) * have an active northshore connect (patient portal) account * persistent uncontrolled asthma in the past 12 months * active prescription for daily ics medication for asthma exclusion criteria: * candidate refusal * the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation

Keywords: asthma uncontrolled asthma asthma medication adherence propeller health connected inhaler system
a study of incb050465 in relapsed or refractory follicular lymphoma

Conditions: Lymphoma

Summary: the purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.


Eligibility criteria:
inclusion criteria: * aged 18 years or older. * histologically confirmed, relapsed or refractory, follicular b-cell non-hodgkin lymphoma (nhl) (follicular lymphoma) grade 1, 2, and 3a. * ineligible for hematopoietic stem cell transplant. * must have been treated with at least 2 prior systemic therapies. * radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging. * must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue. * eastern cooperative oncology group (ecog) performance status 0 to 2. exclusion criteria: * known histological transformation from indolent nhl to diffuse large b-cell lymphoma. * history of central nervous system lymphoma (either primary or metastatic). * prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (pi3kδ) inhibitors, or a pan-pi3k inhibitor. * prior treatment with a bruton's tyrosine kinase inhibitor (eg, ibrutinib). * allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration. * active graft-versus-host disease. * participants positive for hepatitis b surface antigen or hepatitis b core antibody will be eligible if they are negative for hepatitis b virus-deoxyribonucleic acid (hbv-dna). participants positive for anti-hepatitis c virus (hcv) antibody will be eligible if they are negative for hcv-ribonucleic acid (rna).

Keywords: follicular lymphoma non-hodgkin lymphoma (nhl) phosphatidylinositol 3-kinase (pi3k) δ inhibitor
the effects of glimepiride in patients with type 2 diabetes and chronic heart failure

Conditions: Chronic Heart Failure; Type 2 Diabetes; Cardiovascular Mortality; Cohort Study

Summary: thirty years ago, dzau and braunwald introduced the concept of a continuum of cardiovascular diseases and defined them as a series of events caused by numerous related and unrelated risk factors, thus developing to end-stage heart disease through many pathophysiological pathways and processes. owing to treatment concept changes and the urgency of investigating t2d combined with chf, sus are being re-evaluated, of which glimepiride is undoubtedly the most promising.

since the first sulfonylurea (su; tolbutamide) was commercially launched in germany in 1956, sus, as the oldest oral hypoglycemic drugs, have been developed for three generations and are commonly used for patients with t2d. in 2008, the us food and drug administration and european drug administration required cardiovascular safety certification for all hypoglycemic drugs, resulting in increased related clinical trials. currently, data on the relationship between sus and cardiovascular outcomes are limited, and the cardiovascular effects remain controversial in observational studies. third-generation sus, such as glimepiride, are widely used for treating t2d because of their definite hypoglycemic efficacy, relatively low risk of hypoglycemia, convenient daily use, and low price. glimepiride has good cardiovascular safety according to randomized controlled trials (rcts). the proportion of sus used in patients with heart failure is as high as 60.4%. although some studies have shown that sus are neutral in terms of hospitalization rates and adverse cardiovascular events in patients with chf, no standard rct of glimepiride has been conducted to study its effect on the prognosis of patients with t2d and confirmed chf. glimepiride inhibits soluble epoxide hydrolase (seh), thus reducing epoxyeicosatrienoic acid (eet) degradation . increased eet production exerts protective effects on the heart, indicating the potential cardiovascular effect of glimepiride. this retrospective cohort study aimed to evaluate the effects of glimepiride on the clinical outcomes of patients with t2d and chf and provide theoretical evidence for the clinical application of glimepiride in these patients.

Eligibility criteria:
inclusion criteria: * chronic heart failure (\>6 months duration, according to 2021 esc guidelines for the diagnosis and treatment of acute and chronic heart failure) * reduced ejection fraction defined as lvef \< 50% * n-terminal pro-brain natriuretic peptide (nt-probnp) level: \>125 pg/ml * nyha-class ii/iii/iv with stable symptoms for at least the past 3 months * type 2 diabetes (according to the classification and diagnosis of diabetes: standards of medical care in diabetes-2022) exclusion criteria: * those who did not meet the diagnostic criteria * lacked echocardiographic and nt-probnp data * used sulfonylureas other than glimepiride were excluded

Keywords: glimepiride type 2 diabetes chronic heart failure cardiovascular mortality
serum soluble st2 and plaque vulnerability in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: this study aimed to assess the association between serum sst2 level and plaque vulnerability in acs patients. it is hypothesized that serum sst2 level may be related to plaque components and closely associated with plaque vulnerability.

serum soluble suppression of tumorigenicity-2 (sst2) has emerged as a novel biomarker of atherosclerotic disease. this study aimed to investigate whether elevated serum sst2 level is related to coronary plaque components detected on coronary computed tomography angiography (ccta) and plaque vulnerability in non-st elevation acute coronary syndromes (acs) patients. 167 lesions in 120 non-st elevation acs patients were prospectively enrolled and evaluated by ccta in this study. blood were taken from antecubital vein during patient's hospitalization for angiography. serum sst2 level was measured by commerical elisa kits (presage st2 assay kit, critical diagnostics). ccta were performed using a 320-slice ct scanner (aquilion one, toshiba medical systems, otawara, japan). coronary plaque components were analyzed cross each of the lesions using commercialized software package (qangio ct, medis, the netherlands).

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of non-st-elevation acs 1. non-st-elevation myocardial infarction 2. unstable angina 2. age from 18 to 75 years 3. underwent ccta exclusion criteria: 1. patients needed an immediate (\< 2 h) or early invasive strategy (\< 24 h) according to guidelines: 1. haemodynamic instability 2. cardiogenic shock 3. life-threatening arrhythmias or cardiac arrest 4. mechanical complication 5. acute heart failure 6. dynamic st or t wave changes 7. grace score \> 140 2. patients with previous history of: 1. coronary artery bypass graft surgery or percutaneous coronary intervention (pci) 2. immune system disorder 3. tumor 4. acute/chronic infection 5. statin use within 3 months 6. atrial fibrillation 7. end-stage renal failure 8. iodine-containing contrast allergy 3. patients with no significant (≥ 50%) stenosis on major epicardial vessels after ccta performance 4. patients refused subsequent angiography after ccta performance 5. patients with total obstruction on major epicardial vessel 6. patients with insufficient image quality for qangioct analysis

Keywords: soluble st2 plaque vulnerability
the cuff pressure of an endotracheal tube after supine-to-lateral position change

Conditions: Intubation; Pain; Pharyngitis; Hoarseness; Cough

Summary: to compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff

the position of endotracheal tubes depends on the position of the patients. the change of the tube's position is known to influence the pressure of tube's cuff. the shape of the cuff (barrel-shaped versus tapered-shaped) may affect the tube's migration degree because of the difference of the frictional force. the investigator try to compare the the cuff pressure after supine-to-lateral position change between barrel-shaped cuff and taper-shaped cuff.

Eligibility criteria:
inclusion criteria: * patient scheduled for nephrectomy in lateral decubitus position exclusion criteria: * pregnancy * patients with difficult airway * patients with neck motion disorder * patients with history of neck surgery * patients with history of oral and pharyngeal surgery * patients with body mass index \> 35 * patients without teeth
a study comparing xalacom and xalatan in patients with primary open angle glaucoma (poag) or ocular hypertension (oh).

Conditions: Glaucoma; Ocular Hypertension

Summary: this study will examine the efficacy and safety of xalacom comparing with those of xalatan in japanese patients with poag or oh, in order to show superiority of xalacom over xalatan in efficacy and similarity of safety between xalacom and xalatan.


Eligibility criteria:
inclusion criteria: * intraocular pressure is 18 mmhg or more at baseline after treatment with xalatan for 4 weeks or more. exclusion criteria: * history of no-response to timolol * history of trabeculectomy * history of other ocular surgery including alt, slt,and trabeculotomy within 6 months
high flow therapy (hft) to treat respiratory insufficiency in chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Summary: the aim of this study is to see if the vapotherm high flow therapy (hft) device is effective to provide breathing support to patients with chronic obstructive pulmonary disease or copd. the investigators believe that patients using hft will not require as much use of therapies that provide pressure through a face mask, and are already recognized by fda as support therapies for respiratory insufficiency.

the overall objective of this study is to demonstrate that vapotherm high flow therapy (hft) via nasal cannula provides respiratory support to patients with copd as a primary diagnosis, who present with respiratory insufficiency in the emergency department. we intend to demonstrate that vapotherm hft via nasal cannula will result in at least equivalent patient outcomes as the current standard of care, while eliminating the need for other non-invasive respiratory support devices cleared for the treatment of respiratory insufficiency. the current standard of care will include the use of other devices cleared by the fda as respiratory assist devices for the treatment of adult respiratory insufficiency.

Eligibility criteria:
inclusion criteria: * present to the emergency department with a history of copd and with symptoms consistent with a diagnosis of respiratory insufficiency and exacerbation of copd * must be hemodynamically stable as judged by treating clinician in the ed * primary complaint is shortness of breath, and presumed diagnosis is exacerbation of copd exclusion criteria: * fever * radiographic evidence of pneumonia * glasgow coma score \< 14 or unable to correctly answer at least one study-specific question

Keywords: high flow therapy high flow nasal cannula chronic obstructive pulmonary disease respiratory insufficiency
controlled study of ono-5920 in patients with involutional osteoporosis in japan

Conditions: Involutional Osteoporosis

Summary: the purpose of this study is to evaluate the efficacy and safety of ono-5920 in patients with involutional osteoporosis.


Eligibility criteria:
inclusion criteria: 1. a diagnosis in accordance with criteria for the diagnosis of primary osteoporosis. 2. other inclusion criteria as specified in the study protocol. exclusion criteria: 1. patients having secondary osteoporosis or another condition that presents low bone mass. 2. patients having findings that affect measurement of lumbar spinal bone mineral density by dxa 3. patients that have been administered bisphosphonate derivatives. 4. other exclusion criteria as specified in the study protocol.

Keywords: ono-5920, osteoporosis, bisphosphonate